Recall Z-1813-2025 ยท MCM Implant, Cochlear
Advanced Bionics, LLC
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
| Date | May 22, 2025 (initiated Mar 5, 2025) |
| Status | Open, Classified |
| Reason | Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified. |
| Root cause | Under Investigation by firm |
| Action | On 03/06/2025, customer service informed customers via telephone call of a distribution error. An updated "URGENT: Medical Device Recall Notification will be communicated to customers on or about 04/09/2025, via email. This updated notification will inform them that upon further review/investigation, it was identified that the individual package label was for the Marvel M Battery Charger (CI-5607), however the product within the package was a Naida CI PowerCel Charger (CI-5605). Customer are informed that: 1. The mislabeled battery charger they received was from lot either Lot Numbers: 4104 |
| Quantity | 6 chargers |
| Distribution | U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.